Cold ApplicationNCT07359326
The Effect of Cold Application in Patients With Rheumatoid Arthritis
A study testing Cold Application in people with Cold Application and Pain, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
The aim of this thesis is to examine the effects of cold application on pain, disease activity, and quality of life in patients with Rheumatoid Arthritis. Currently, non-pharmacological interventions, such as cold therapy, are utilized less frequently than pharmacological treatments for the management of pain in… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cold Application, Pain, Disease Activity
- What is being tested?
- Cold Application
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Oct 2024to 29 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having been diagnosed with rheumatoid arthritis at least 6 months ago,
- No problems with speaking, communicating, hearing, or understanding,
- Able to understand and speak Turkish,
- Experiencing pain.
Who cannot join
- Patients who are in remission
- Individuals of foreign nationality
- People with psychiatric or mental illnesses
- Patients who do not consent to participate in the study or who withdraw at any stage of the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Faculty of health sciences Saglik Bilimleri University
Istanbul
About this study
Official title: The Effect of Cold Application on Pain, Disease Activity and Quality of Life in Patients With Rheumatoid Arthritis
The aim of this thesis is to examine the effects of cold application on pain, disease activity, and quality of life in patients with Rheumatoid Arthritis.
Currently, non-pharmacological interventions, such as cold therapy, are utilized less frequently than pharmacological treatments for the management of pain in inflamed joints. Cold application is anticipated to alleviate pain and consequently enhance patients' quality of life. This study seeks to improve quality of life by reducing pain in patients with Rheumatoid Arthritis. Given its simplicity, ease of application, and low cost, this intervention may be recommended as a pain management strategy both for patients and for nurses working in clinical settings. Furthermore, the study aims to contribute to the existing literature on the subject.
- Conditions
- Cold Application, Pain, Disease Activity, Rheumatoid Arthritis (RA
- Being tested
- Cold Application
- Medical subject headings
- Pain, Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold ApplicationBehavioural
Patients will be instructed to apply cold therapy three times daily for 15 minutes each session over a period of three weeks. Patients will report their daily cold application to the researcher via text message. For those unable to provide updates via text, the researcher will follow up daily by phone to monitor adherence to the intervention.
| Study group | Role | What they receive |
|---|---|---|
| Cold Application Group | Experimental | Patients will be instructed to apply cold therapy three times daily for 15 minutes each session over a period of three weeks. Patients will report their daily cold application to the researcher via text message. For those unable to provide updates via text, the researcher will follow up daily by phone to monitor adherence to the intervention. Receives: Behavioral: Cold Application |
| Control Group | No intervention | This patient group will undergo follow-up assessment after a three-week period during which no intervention will be administered. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rheumatoi Arthritis Disease Activity Index-5
The Rheumatoid Arthritis Disease Activity Index-5 (RADAI-5) is a patient-reported outcome measure designed to assess disease activity in individuals with rheumatoid arthritis
Measured: 3 weeks
Secondary outcomes (1)
The Short Form Health Survery- SF-36
The Short Form-36 (SF-36) is a widely used generic health-related quality of life (HRQoL) questionnaire designed to assess overall physical and mental well-being. It is a self-administered instrument that evaluates health status across multiple dimensions, making it suitable for clinical practice, research, and population health surveys.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start14 Oct 2024
- Primary completion30 Jan 2026
- Study completion29 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cold ApplicationStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2 group with conventional therapy control group
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Betül ERTEN, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07359326
- Sponsor's protocol ID
- SBU-SBF-BE-01
- Status last verified
- Apr 2026
- First submitted
- 14 Jan 2026
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Cold Application on Pain, Disease Activity and Quality of Life in Patients With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT07359326
- Acronym / sponsor ID
- SBU-SBF-BE-01
- Conditions
- Cold Application, Pain, Disease Activity, Rheumatoid Arthritis (RA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 14 Oct 2024 (actual)
- Primary completion
- 30 Jan 2026 (actual)
- Study completion
- 29 Mar 2026 (actual)
- First posted
- 22 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this thesis is to examine the effects of cold application on pain, disease activity, and quality of life in patients with Rheumatoid Arthritis.
Currently, non-pharmacological interventions, such as cold therapy, are utilized less frequently than pharmacological treatments for the management of pain in inflamed joints. Cold application is anticipated to alleviate pain and consequently enhance patients' quality of life. This study seeks to improve quality of life by reducing pain in patients with Rheumatoid Arthritis. Given its simplicity, ease of application, and low cost, this intervention may be recommended as a pain management strategy both for patients and for nurses working in clinical settings. Furthermore, the study aims to contribute to the existing literature on the subject.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 2 group with conventional therapy control group
| Arm | Type | Receives |
|---|---|---|
| Cold Application Group | Experimental | Behavioral: Cold ApplicationPatients will be instructed to apply cold therapy three times daily for 15 minutes each session over a period of three weeks. Patients will report their daily cold application to the researcher via text message. For those unable to provide updates via text, the researcher will follow up daily by phone to monitor adherence to the intervention. |
| Control Group | No intervention | –This patient group will undergo follow-up assessment after a three-week period during which no intervention will be administered. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Having been diagnosed with rheumatoid arthritis at least 6 months ago,
- No problems with speaking, communicating, hearing, or understanding,
- Able to understand and speak Turkish,
- Experiencing pain.
Key exclusion criteria (4 listed)
- Patients who are in remission
- Individuals of foreign nationality
- People with psychiatric or mental illnesses
- Patients who do not consent to participate in the study or who withdraw at any stage of the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cold ApplicationPatients will be instructed to apply cold therapy three times daily for 15 minutes each session over a period of three weeks. Patients will report their daily cold application to the researcher via text message. For those unable to provide updates via text, the researcher will follow up daily by phone to monitor adherence to the intervention. | Behavioural | Cold Application Group |
Primary outcome
Rheumatoi Arthritis Disease Activity Index-5
Time frame: 3 weeks
The Rheumatoid Arthritis Disease Activity Index-5 (RADAI-5) is a patient-reported outcome measure designed to assess disease activity in individuals with rheumatoid arthritis
1 secondary outcome
The Short Form Health Survery- SF-36
Time frame: 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Individual participant dataSharing planned: No
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Study of Tolerance to the Application of Cold Plasma in the Treatment of Chronic Wounds
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Intraoperative Application of Cold Atmospheric Plasma to Prevent Postoperative Wound Complications in the Inguinal Region of High-risk Patients With Peripheral Arterial Occlusive Disease
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cold Application in people with Cold Application and Pain, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rheumatoi Arthritis Disease Activity Index-5 (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.